Study to Assess the Safety, Tolerability, and Pharmacokin... | NCT01352884

NCT01352884

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
GlaxoSmithKline	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage 1	Experimental	Stage 1 will identify the recommended Stage 2 dose using a dose-escalation process. Dose-escalation will continue until either a maximum tolerated dose is established, or a therapeutic dose is reached.	Drug: AMP-224
Stage 2	Experimental	Stage 2 will further explore the safety, pharmacokinetics, and preliminary clinical activity of AMP-224 in at least one tumor type based on pharmacodynamic assessments and clinical activity emerging from the Dose-Escalation Phase. Tumor tissue and blood specimens will be evaluated for pharmacodynamic markers/activity at specified timepoints throughout the study.	Drug: AMP-224

Name	Type	Description	Arm Group Labels	Other Names
AMP-224	Drug	Escalating doses of AMP-224	Stage 1
AMP-224

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with adverse events.		From start of study drug administration until the date of first documented progression or date of death from any cause; through Day 56 of final cycle.
Number of participants with dose-limiting toxicities.		From start of study drug administration until the date of first documented progression or date of death from any cause: through Day 56 of the final cycle.
Number of participants with changes in laboratory values, vital signs, physical exam, and electrocardiogram.		From start of study drug administration until the date of first documented progression or date of death from any cause: through Day 56 of the final cycle.
Determine Maximum Tolerated Dose based on the occurrence of dose-limiting toxicities.		From start of study drug administration through Day 28 of Cycle 1.
Determine Recommended Phase 2 Dose following analysis of adverse events, pharmacokinetics and changes in laboratory evaluations.		From start of study drug administration until withdrawal; through Day 56 of final cycle.

Secondary Outcomes

Measure	Description	Time Frame
Evaluate pharmacokinetics, including area under the plasma concentration versus time curve (AUC), peak plasma concentration (Cmax) and clearance of AMP-224 following single and repeat doses of AMP-224.		From Day 0 pre-dose through Day 56 of final cycle.
Evaluate Overall Response Rate (ORR), including Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progression-Free Survival (PFS).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be able to provide informed consent
In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma that has relapsed and is refractory to standard therapy, or for which no standard therapy exists
In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or cytologically confirmed
Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and must not have received more than 2 prior chemotherapeutic regimens
Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV disease that is surgically incurable and unresectable
Melanoma patients with documented BRAF mutation that is known to be responsive to BRAF inhibitors must have failed or be intolerant to such inhibitors
Must have measurable disease
Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry
Must by at least 18 years old
Must have adequate organ function

Exclusion Criteria:

Prior cancer therapies must have completed at least 14 days or 5 half-lives (whichever is longer) prior to first dose of AMP-224
Prior treatment with an anti-PD1 antibody therapy
Known antibody response against prior antibody therapy or fusion protein therapeutics
Major surgery within 4 weeks prior to first dose of AMP-224
Prior allogeneic or autologous bone marrow or organ transplantation
Known and/or a history or evidence of autoimmune disease except vitiligo, resolved childhood asthma and stable hypothyroidism
Received an immunomodulatory drug within 2 weeks of first dose of AMP-224
Active infections requiring antibiotics, physician monitoring, or recurrent fevers >100.4 degrees fahrenheit associated with a clinical diagnosis of active infection
Patients with cirrhosis
Clinically significant cardiac or electrocardiogram abnormalities
History or evidence of HIV
Active viral disease (except when the viral infection is associated with the malignancy)
Regular use of illicit drugs or a recent history of substance abuse
Pregnant or breastfeeding women

Facility	Status	City	State	ZIP	Country	Contacts
Karmanos Cancer Institute		Detroit	Michigan	48201	United States
Memorial Sloan Kettering Cancer Center

ID	Term
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009385	Neoplastic Processes
D010335	Pathologic Processes